Saw palmetto (Serenoa repens) is a small, shrub-like palm that grows in the southeastern United States. The saw palmetto produces leaves with one-ribbed segments and a seed stalk in late spring. The stalk produces flowers which develop a hard green fruit about the size of an olive with one seed. The fruit ripens in the summer and turns various shades of yellow, orange and black. The fruit is harvested in late summer, and typically yields several hundred pounds of berries per acre.
Saw palmetto berries have been consumed and used by Native Americans for many centuries for various purposes. In recent times, a tea made from saw palmetto berries has been used as a mild diuretic and for genitourinary treatments. Various herbs and plant materials have been commonly used in various parts of the world for centuries for medicinal uses. In recent years in the United States, plant materials including saw palmetto berries have shown increased use to treat various illnesses. The plant or botanical materials are typically used in the form of powders or extracts made from one or more plants. The extracts can be obtained from the whole plant or from selected parts such as the leaves, seeds or roots. The resulting powder and extracts are a complex mixture of various compounds and can contain many biologically active and biologically inactive compounds.
The complex nature of plant materials and plant extracts make it difficult to identify the active components and isolate the active an inactive compounds. The complex nature of the extracts also makes it difficult to control the amount or ratio of the various components and the concentration of the compounds within the extracts. The variations in chemical composition from different batches of plant materials obtained from different harvests results in inconsistent treatments. However, the complex nature of the various bioactive components in botanical materials provide the potential for identifying and utilizing various synergistic bioactive profiles.
A great deal of effort has been spent on identifying the various components in the plant materials, and particularly the extracts. The ability to isolate and identify the components has increased with the development of improved chemical separation and analytical technology. The isolation and purification of various compounds from plant materials has been a common form of drug research. There has also been an increased interest in studying the complex medicinal and biological activities. Many plant extracts have potent activities, but the variations in the compositions result in unpredictable and inconsistent properties.
The saw palmetto berry has been used for a variety of purposes. The saw palmetto berry has been used to make a tea or infusion, dried and ground to a powder or to obtain an oil extract. One common use is the treatment of benign prostatic hypertrophy. The saw palmetto berry extract has been shown to be nontoxic and has demonstrated few or no adverse side effects. One example of a process for obtaining and determining the bioactivity of the extract of the saw palmetto berry is disclosed in U.S. Pat. No. 6,039,950 to Khwaja et al.
U.S. Pat. No. 6,197,309 to Wheeler discloses a composition for treating prostate disorders. The composition includes a mixture of various vitamins, amino acids and plant materials. The plant materials include a mixture of saw palmetto berries, pumpkin seeds, stinging nettle, garlic and Ginkgo leaves.
U.S. Pat. No. 6,241,987 to Lam discloses a dietary supplement for supporting and maintaining prostate gland function. The composition contains a mixture of saw palmetto oil extracts, pumpkin seed extract and nettle root extract. The combination of the extracts are purported to provide a synergistic effect.
Plant extracts are obtained by various processes depending on the desired composition of the resulting extract. Typically, the extracts are obtained from the dried plant material by liquid extraction. The liquid extraction can use water, alcohol or various other organic solvents. One common extraction process uses liquid or supercritical carbon dioxide. An example of a carbon dioxide extraction process of saw palmetto berries is disclosed in U.S. Pat. No. 6,319,524 to Gregg.